Department of Health and Human Services January 11, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop and vendor display on the use of electronic track and trace technology to combat counterfeit drugs. The purpose of the meeting is as follows: To identify incentives for widespread adoption of radio- frequency identification (RFID), as well as obstacles to the adoption of RFID across the U.S. drug supply chain and possible solutions to those obstacles; to solicit comment on the implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and the use of an electronic pedigree (e-pedigree); and to learn the state of technology development related to electronic track and trace and e- pedigree technology solutions. To address these issues, we are inviting interested individuals, organizations, and other stakeholders to present information to FDA's Counterfeit Drug Task Force. We are also inviting vendors of track and trace technologies and e-pedigree solutions relevant to the drug distribution system to display their products for the educational benefit of FDA and attendees. (For this meeting, we are only interested in displays from vendors of track and trace technology and e-pedigree solutions for the PDMA requirement, as opposed to covert or overt counterfeiting technologies, such as holograms or color-shifting inks.)

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of monensin Type C medicated feeds in component feeding systems (including top dress) for increased milk production efficiency in dairy cows.